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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMICONSTRAINED
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OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMICONSTRAINED Back to Search Results
Catalog Number HC-21001-HA
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 02/28/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.
 
Event or Problem Description
A complaint was initiated for a patient who underwent hip revision surgery on (b)(6) 2018.The original surgery is dated (b)(6) 2013.The reason for revision is reported patient pain.
 
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Brand Name
OMNI HIP SYSTEM
Common Device Name
PROSTHESIS, HIP, SEMICONSTRAINED
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham MA 02767
MDR Report Key8936228
Report Number1226188-2019-00127
Device Sequence Number617891
Product Code LPH
UDI-Device Identifier00841690115779
UDI-Public00841690115779
Combination Product (Y/N)N
PMA/510(K) Number
K090845
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date05/31/2017
Device Catalogue NumberHC-21001-HA
Device Lot Number11671
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/30/2019
Initial Report FDA Received Date08/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age71 YR
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